[Editor's note:Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker and at MedDeviceTracker.]
The US FDA approved one original PMA between 9 April and 15 April.
Global Device Approvals Snapshot: April 16-22, 2019
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved BaroNova's TransPyloric Shuttle and its delivery system to treat obesity. It also cleared NeuroSigma’s Monarch external trigeminal nerve stimulation system, making it the first FDA-approved device for treating attention deficit hyperactivity disorder.
More from Approvals
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
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Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
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Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.